WO2025150034A2 - Insufflateur, appareil d'insufflation et procédé d'insufflation dans un vaisseau du corps d'un sujet humain ou animal - Google Patents

Insufflateur, appareil d'insufflation et procédé d'insufflation dans un vaisseau du corps d'un sujet humain ou animal

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Publication number
WO2025150034A2
WO2025150034A2 PCT/IE2025/000001 IE2025000001W WO2025150034A2 WO 2025150034 A2 WO2025150034 A2 WO 2025150034A2 IE 2025000001 W IE2025000001 W IE 2025000001W WO 2025150034 A2 WO2025150034 A2 WO 2025150034A2
Authority
WO
WIPO (PCT)
Prior art keywords
vessel
lesion
location
topography
pressure
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IE2025/000001
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English (en)
Other versions
WO2025150034A3 (fr
Inventor
John O'dea
Giovanni DI NAPOLI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Palliare Ltd
Original Assignee
Palliare Ltd
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Filing date
Publication date
Application filed by Palliare Ltd filed Critical Palliare Ltd
Publication of WO2025150034A2 publication Critical patent/WO2025150034A2/fr
Publication of WO2025150034A3 publication Critical patent/WO2025150034A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
    • A61M13/003—Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00004—Operational features of endoscopes characterised by electronic signal processing
    • A61B1/00009—Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope
    • A61B1/000094—Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope extracting biological structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00004—Operational features of endoscopes characterised by electronic signal processing
    • A61B1/00009—Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope
    • A61B1/000096—Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope using artificial intelligence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/31—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the rectum, e.g. proctoscopes, sigmoidoscopes, colonoscopes
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/20—ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/40—ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/70—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3344—Measuring or controlling pressure at the body treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1064—Large intestine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1067—Anus

Definitions

  • the present invention relates to insufflating apparatus for insufflating a vessel in the body of a human or animal subject, and in particular, though not limited to an insufflating apparatus for insufflating a vessel to permit detection of a lesion in or on an inner surface of a wall of the vessel, and preferably, for also detecting a lesion in or on an inner surface of a wall of the vessel.
  • the invention also relates to an insufflator for insufflating a vessel in the body of a human or animal subject to permit detection of a lesion in or on an inner surface of a wall of the vessel.
  • the invention provides a method for insufflating a vessel in the body of a human or animal subject to permit detection of a lesion in or on an inner surface of a wall of the vessel and also for detecting a lesion in or on an inner surface of the wall of the vessel.
  • the invention also relates to an insufflating apparatus for insufflating a vessel so that the inner surface of a wall of the vessel adjacent a targeted area thereof is of a predefined degree of evenness
  • the invention also relates to an insufflator and a method for insufflating a vessel so that an inner surface of a wall of the vessel adjacent a targeted area thereof is of a predefined degree of evenness.
  • the invention further relates to an insufflating apparatus, an insufflator and a method for insufflating a vessel to a predefined pressure value so that an inner surface of the wall of the vessel adjacent a targeted area thereof is of a predefined degree of evenness.
  • a colonoscopy procedure has become a main stay of colorectal cancer prevention, and entails the passage of a colonoscope or an endoscope anally through the rectum and in turn through the colon as far as the cecum.
  • the colonoscope allows detection of lesions, such as pre-cancerous lesions, as well as pre-cancerous adenomas and/or pre-cancerous polyps hereinafter collectively referred to as lesions whether pre-cancerous or cancerous.
  • lesions are typically removed using a snare instrument in order to prevent their further progression to become cancerous.
  • the colon comprises a series of folds which tend to obscure or hide such lesions, thereby making it difficult, and in some cases almost impossible to detect such lesions, particularly pre-cancerous lesions, which, in general, are of a relatively small size.
  • the colon is insufflated, typically, through a colonoscope to flatten the folds of the colon, particularly adjacent a targeted area being inspected for the detection of such lesions, which is within the visualisation of the distal end of the colonoscope. This requires insufflating the colon to relatively high pressures, and in many cases to pressures as high as 25mmHg to 30mmHg.
  • the present invention is directed towards providing an insufflating apparatus and an insufflator for insufflating a vessel in the body of a human or animal subject which addresses at least some of these problems.
  • the invention is also directed towards providing a method for insufflating a vessel in the body of a human or animal subject which addresses at least some of these problems.
  • procedure as used throughout this specification is intended to refer to any minimally invasive procedure, be it an investigative, a surgical or other such procedure.
  • vessel as used throughout this specification is intended to mean any vessel, lumen or cavity in the body of a human or animal subject which may be insufflated.
  • the reduce pressure signal comprises a manually generated reduce pressure signal
  • the reduce pressure signal comprises a manually generated reduce pressure signal by operating an electrical switch, which may be a foot pedal operated electrical switch and/or a hand operated electrical switch.
  • the reduce pressure signal is produced in response to detection of a lesion in the targeted area.
  • the vessel pressure is maintained at the elevated pressure or the reduced pressure while the lesion present signal or the reduce pressure signal remains active, or until a return signal is applied to the control means to return the vessel pressure to the pressure at which the vessel had been maintained prior to the vessel pressure being increased to the elevated pressure or decreased to the reduced pressure from the vessel pressure.
  • the location signal indicative of the location of the targeted area in the vessel is derived from a signal indicative of the location of an endoscope in the vessel, and preferably, the location signal indicative of the location of the targeted area in the vessel is derived from a signal indicative of the location of an endoscope through which the procedure is being carried out at the targeted area.
  • the location signal indicative of the location of the targeted area in the vessel is determined in response to a signal indicative of the location of a distal end of the endoscope in the vessel.
  • the location signal indicative of the location of a targeted area in the vessel is manually generated, and preferably, is manually generated by a foot pedal operated electrical switch, or by a hand operated electrical switch.
  • control means comprises a signal processor, and preferably, a microprocessor.
  • the monitoring means is adapted to monitor a scale on the endoscope as the endoscope is being urged into and/or out of the body of the subject, the scale being readable by the monitoring means, and preferably, the scale comprises a graduated scale, and advantageously, a graduated scale comprising a plurality of graduations spaced apart longitudinally along the endoscope, and preferably, longitudinally equi-spaced apart graduations.
  • the predefined degree of evenness of the inner surface of the vessel wall adjacent the targeted area is set to permit detection of a lesion in or on the inner surface of the vessel wall adjacent the targeted area.
  • the predefined degree of evenness of the targeted area of the inner surface of the vessel wall comprises a substantially flat surface.
  • the degree of evenness of the topography of the reference surface of each topography reference image is different to the degrees of evenness of the topographies of the reference surfaces of the other topography reference images.
  • the topography reference images are stored cross-referenced with corresponding values indicative of the degrees of evenness in a topography reference image look-up table in the topography reference image storing means.
  • the topography reference images are derived from a reference vessel corresponding to the vessel.
  • a plurality of the topography reference images of reference surfaces for different locations in a reference vessel corresponding to the vessel are stored in the topography reference image storing means.
  • the topography reference images of the reference surfaces of the topographies of the different degrees of evenness for each location of a reference vessel for which topography reference images are stored are stored and cross-referenced with the values indicative of the degrees of evenness of the respective topography reference surfaces in the topography reference image storing means, and preferably, are stored and cross-referenced with the corresponding values of the degrees of evenness in the topography reference image look-up table stored in the topography reference image storing means.
  • the image recognition means is adapted to determine the degree of evenness of the topography of the inner surface of the vessel wall of the captured image of the targeted area as the degree of evenness of the topography reference image that is a match or a best match of the captured image.
  • the image recognition means is adapted to produce the topography signal to be of value corresponding to the value of the degree of evenness of the topography reference image which is a match with or the best match with the captured image.
  • a plurality of topography reference images of reference surfaces of topographies of respective different degrees of evenness are stored for different vessels in the topography reference image storing means.
  • the topography reference images are updated by an artificial intelligence algorithm.
  • the topography reference images are updated each time a match or a best match of a captured image is made with one of the topography reference images and the captured image is stored as an additional topography reference image along with the corresponding topography reference image and/or the corresponding additional topography reference images.
  • each captured image for which a match or a best match with a topography reference image is made is passed through a learning model prior to being stored as an additional topography reference image, and preferably, the number of additional topography reference images stored corresponding to each degree of evenness is limited to a predefined number of additional topography reference images, and each time the number of additional topography reference images for each degree of evenness exceeds the predefined number, the oldest one of the additional topography reference images for that degree of evenness is deleted.
  • a detecting means for detecting a lesion in or on the inner surface of the vessel wall adjacent the targeted area, and preferably, the image recognition means comprises the detecting means.
  • control means is responsive to the topography signal being indicative of the inner surface of the vessel wall adjacent the targeted area being of the predefined degree of evenness to produce a lesion scan signal.
  • the image recognition means is responsive to the lesion scan signal to compare a captured image of the inner surface of the vessel wall of the targeted area with at least one lesion reference image of a representation of a reference lesion, and on determining the presence of a lesion in or on the inner surface of the vessel wall of the targeted area, to produce a lesion present signal indicative of the detection of a lesion.
  • the image recognition means is adapted to compare the captured image of the inner surface of the vessel wall of the targeted area with a plurality of lesion reference images of lesions of respective different types and/or respective different sizes.
  • the image recognition means is adapted to determine the presence of a lesion in response to a match or a best match of the captured image with the at least one lesion reference image being determined, and preferably, a plurality of lesion reference images are stored in the lesion reference image storing means and preferably, the lesion reference image storing means is accessible to the image recognition means.
  • the lesion reference images comprise respective representations of lesions of different types, and preferably, lesions of different sizes.
  • the at least one lesion reference image is stored in a lesion reference image storing means cross-referenced with an identity of the type and size of the lesion.
  • the image recognition means is adapted to compare the captured image of the inner surface of the vessel wall of the targeted area sequentially with the lesion reference images, and preferably, the image recognition means is adapted to compare the captured image of the inner surface of the vessel wall of the targeted area sequentially with the lesion reference images.
  • the image recognition means is adapted to determine the location of a detected lesion in or on the inner surface of the vessel wall adjacent the targeted areas.
  • the image recognition means is adapted to produce the lesion present signal comprising data indicative of the location of the lesion in or on the inner surface of the vessel wall adjacent the targeted area.
  • At least one of the predefined pressure values is stored for each one of a plurality of different vessels.
  • At least one predefined pressure value is stored for each one of a plurality of different vessels.
  • the location of the endoscope in the vessel is determined by fluoroscopic monitoring of a fluoroscopic opaque marker on the endoscope, and preferably, the fluoroscopic opaque marker is located adjacent the distal end of the endoscope.
  • the fluoroscopic opaque marker comprises a radiopaque marker.
  • the characteristic to which the at least one of the reference images of the relevant location in the reference vessel relates is the sex of a subject.
  • the characteristic to which the at least one of the reference images of the relevant location in the reference vessel relates is a body mass index or a body mass index range of a subject.
  • the at least one characteristic of a subject comprises one or more of the sex of a subject, the age of a subject or the age range of a subject, the weight of a subject or the weight range of a subject, the body mass index of a subject or the body mass index range of a subject and/or the resting position of the subject during the procedure.
  • the image recognition means determines the location of the targeted area in the vessel as the location of the location reference image with which the captured image is a match or a best match.
  • the location reference images are stored in a location reference image look-up table accessible to the image recognition means.
  • the location reference images are cross-referenced with the identities of the corresponding locations thereof and the identities of the characteristics and types thereof with which they correspond in the location reference image look-up table.
  • the location reference images are grouped into respective groups thereof relating to one or more of the following types of characteristics of a subject, the sex of a subject, the age of a subject or the age range of a subject, the weight of a subject or the weight range of a subject, the body mass index of a subject or the body mass index range of a subject, and/or the rest position of a subject during the procedure.
  • the image recognition means is adapted to compare the captured image sequentially with the respective location reference images in each group thereof on a group by group basis.
  • location reference images for each location of the vessel are updated each time a match or a best match of a captured image with a location reference image is obtained for that location, and the captured image which is matched is passed through a learning model and stored as an additional location reference image along with the corresponding location reference image or additional location reference images for that location.
  • the number of additional location reference images for each one of the location is maintained at a predefined number of location reference images, and each time the number of additional location reference images for each location exceeds the predefined number of additional location reference images, the oldest one of the additional location reference images for that location is deleted.
  • the additional location reference images are generated by an artificial intelligence algorithm.
  • the captured image of the targeted area is captured by an image capturing device of an endoscope.
  • the image capturing means of the endoscope is located adjacent a distal end of the endoscope.
  • the insufflating gas is supplied to the vessel through a flow controller operated under the control of a control means.
  • control means is responsive to the location signal for operating the flow controller to deliver the insufflating gas to the vessel at the predefined pressure value corresponding to the location of the targeted area in the vessel.
  • control means is responsive to the lesion present signal for operating the flow controller to increase the flow of insufflating gas to the vessel to increase the vessel pressure by the preset pressure increase amount.
  • control means is responsive to the pressure reduce signal for operating the flow controller to reduce the flow of insufflating gas to the vessel to reduce the vessel pressure from the current vessel pressure by the preset pressure reduction amount.
  • the predefined pressure values for the targeted areas in the respective locations of the vessel lie in the range of 5mmHg to 30mmHg.
  • the elongated lumen comprises a colon of a subject.
  • one of the locations of the colon for which at least one predefined pressure value is stored comprises the sigmoid colon.
  • the preset pressure reduction amount is preset or is selectable.
  • the lesion present signal is derived from the image recognition means.
  • the image recognition means compares the captured image of the inner surface of the vessel wall of the targeted area with at least one lesion reference image comprising a representation of at least one lesion to determine the presence of a lesion in or on the inner surface of the vessel wall of the targeted area.
  • the image recognition means compares the captured image of the inner surface of the vessel wall of the targeted area of the predefined degree of evenness with the at least one lesion reference image.
  • the image recognition means compares the captured image with a plurality of lesion reference images comprising images of different types of lesions and of different sizes thereof.
  • the lesion reference images are stored and cross referenced with the identity of the type of lesion and the identity of the size thereof.
  • each captured image is sequentially compared with the images of each group of lesion reference images on a group-by-group basis.
  • an image of the captured image of the targeted area comprising a lesion therein is displayed on a visual display screen.
  • the lesion in the image displayed on the visual display screen is highlighted, and preferably, is highlighted by encircling the image of the lesion with a bright ring.
  • each additional lesion reference image is determined by an artificial intelligence algorithm.
  • each captured image is compared with each of the lesion reference images and the additional lesion reference images.
  • At least one of the lesion reference images is derived from a reference vessel of a subject having at least one type of at least one characteristic.
  • the at least one characteristic of a subject comprises one or more of the sex of a subject, the age of a subject or the age range of a subject, the weight of a subject or the weight range of a subject, the body mass index or the body mass index range of a subject and the resting position of the subject during the procedure.
  • the lesion is removed by a snaring instrument extending through an endoscope to the targeted area of the inner surface of the vessel wall of the vessel.
  • the supply of insufflating gas to the vessel is controlled by a flow controller operated under the control of a control means, and the control means is responsive to the topography signal for controlling the supply of the insufflating gas to the vessel for maintaining the inner surface of the vessel wall of the targeted area at the predefined degree of evenness.
  • the control means is responsive to the lesion present signal for operating the flow controller to increase the flow of insufflating gas to the vessel to increase the vessel pressure by the preset pressure increase amount.
  • control means is responsive to the reduce pressure signal for operating the flow controller to reduce the flow of insufflating gas to the vessel to reduce the vessel pressure by the present pressure reduction amount.
  • the vessel comprises the colon of a subject, and preferably, the endoscope comprises a colonoscope, advantageously, entered anally into the colon of the subject.
  • the lesion comprises one of a pre-cancerous lesion, a pre-cancerous adenoma or a pre-cancerous polyp.
  • the invention provides a method for insufflating a vessel for maintaining the topography of an inner surface of a wall of the vessel (vessel wall) of a targeted area in the vessel at a predefined degree of evenness, the method comprising reading a topography signal from a vision system indicative of the degree of evenness of the topography of the inner surface of the vessel wall of the targeted area, and controlling the flow of insufflating gas to the vessel for maintaining the topography of the inner surface of the vessel wall of the targeted area at a predefined degree of evenness.
  • the topography signal is read from an image recognition means adapted to compare a captured image of the inner surface of the vessel wall of the targeted area with at least one topography reference image, at least one of the at least one topography reference images having a reference surface of topography of the predefined degree of evenness.
  • Fig. 10 is a block representation of an insufflating apparatus according to another embodiment of the invention for carrying out a method for insufflating a vessel also according to the invention in a human or animal subject and for detecting a lesion in the vessel,
  • Fig. 11 is a view of a colon of a subject with a part of the insufflating apparatus of Fig. 10 inserted into the colon
  • Fig. 12 illustrates a location reference image look-up table for use in the insufflating apparatus of Fig. 10,
  • Fig. 14 is a block representation of an insufflating apparatus according to a still further embodiment of the invention for carrying out a method for insufflating a vessel, also according to the invention in a human or animal subject and for detecting a lesion in the vessel.
  • insufflating apparatus for insufflating a vessel, in this case, the colon 7 of a human subject 8 to a pressure dependent on the location of a targeted area 11 of the colon 7, at which a procedure is being carried out, as will be described below.
  • the procedure is a procedure in which the insufflating apparatus 1 is adapted to detect a lesion, such as a pre-cancerous lesion, a pre-cancerous adenoma and/or a pre-cancerous polyp, discussed below, in the colon 7, and to remove the detected lesion therefrom.
  • the insufflator 3 comprises a housing 19 illustrated in broken lines in Fig. 1, within which a flow controller 20 is located.
  • a first inlet port 21 in the housing 19 is provided for connecting the insufflator 3 to an insufflating gas source 22.
  • the insufflating gas source may be any suitable gas source, for example, a pressurised supply of carbon dioxide, which is readily available in an operating theatre of a hospital.
  • the flow controller 20 receives the insufflating gas from the insufflating gas source 22 through the first inlet port 21.
  • the age ranges included in column three will be, for example, an age range which will cover infants, an age range which will cover children up to, for example, twelve years of age, an age range which will cover teenagers, typically, from thirteen to twenty-four, and possibly two further age ranges of adults, for example, from twenty-five to fifty-five and from fifty-six upwards.
  • the body mass index ranges for subjects include a body mass index range for subjects of a normal body mass index range, subjects of an obese body mass index range, subjects of an extra obese body mass index range and subjects of a body mass index range below a normal body mass index range.
  • the resting positions of a subject during the procedure may, for example, be a left lateral resting position as illustrated in Fig.
  • a means for generating a lesion present signal indicative of a lesion having been detected in or on the inner surface 14 of the colon wall 15 in the current targeted area 11 in this embodiment of the invention comprises a manually operated electrical switch located externally of the housing 19 of the insufflator 3.
  • the manually operated switch for generating the lesion present signal comprises a foot pedal operated electrical switch 42.
  • the foot pedal operated electrical switch 42 is connected to the microprocessor 30 through the housing 19 of the insufflator 3, and is operated by a surgeon or clinician on detecting a lesion in the current targeted area 11 in the colon 7, such that by depressing a foot pedal 43 of the foot pedal operated electrical switch 42, the electrical switch 42 is operated from an open circuit state to a closed circuit state to produce the lesion present signal.
  • the monitoring unit 32 With the subject 8 lying on an operating table 44 or other suitable support in the appropriate rest position, for example, the left lateral position as illustrated in Fig. 4, the monitoring unit 32 is secured to the body of the subject 8 adjacent the anus 35.
  • the colonoscope 5 is then entered through the monitoring unit 32 through the anus 35 and the rectum 36 into the colon 7.
  • the microprocessor 30 operates the flow controller 20 to commence insufflating the colon 7.
  • the colonoscope 5 is urged through the colon 7 until the distal end 10 of the colonoscope 5 is adjacent the cecum 39 of the colon 7.
  • the colonoscope 5 comprises a visual display screen 6 on which images of targeted areas 11 in the colon 7, which are captured by an image capturing device 9 of the colonoscope 5, are displayed.
  • the image capturing device 9 is located adjacent the distal end 10 of the colonoscope 5 and captures images of the targeted areas 11 of the colon 7 just distally of the distal end 10 of the colonoscope 5.
  • the microprocessor 30 counts the signals indicative of the detection of the graduations, and the microprocessor 30 is programmed to determine the length of the colon 7 of the subject between the transitioning of the sigmoid colon 41 to the rectum 36 and the cecum 39 from the count of the graduations and the signals inputted through the touchscreen interface 31 to the microprocessor 30 indicating the locations of the distal end 10 of the colonoscope 5 adjacent the transitioning of the sigmoid colon 41 to the rectum 36 and being adjacent the cecum 39.
  • the microprocessor 30 is also programmed to determine the lengths of the sigmoid colon 41, the descending colon 45, the transverse colon 40 and the ascending colon 46 from the counts of the signals indicative of the detection of the graduations 33 on the colonoscope 5 and the signals inputted through the touchscreen interface 31 to the microprocessor 30 indicating the locations of the distal end 10 of the colonoscope 5 being adjacent the transitioning of the sigmoid colon 41 to the rectum 36, the transitioning of the sigmoid colon 41 to the descending colon 45, the transitioning of the descending colon 45 to the transverse colon 40, the transitioning of the transverse colon 40 to the ascending colon 46, and the cecum 39.
  • the signal produced by the monitoring unit 32 which contains a count of the graduations 33 on the colonoscope 5, as the colonoscope 5 is being withdrawn through the colon 7 from the cecum 39 is effectively a location signal indicative of the current location of the distal end 10 of the colonoscope 5, and in turn is indicative of the current location of the targeted area 11.
  • the surgeon or clinician commences to slowly withdraw the colonoscope 5 through the colon 7, and as the colonoscope 5 is being withdrawn through the colon 7, the surgeon or clinician manoeuvres the distal end 10 of the colonoscope 5 in order to scan the entire inner surface 14 of the colon wall 15 from one targeted area 11 to the next targeted area 11 as the targeted areas 11 of the colon wall sequentially come within the field of view of the image capturing device 9 of the colonoscope 5 and are displayed on the visual display screen 6 of the colonoscope 5.
  • the microprocessor 30 monitors the value of the location signal from the monitoring unit 32 in order to determine the location of the distal end 10 of the colonoscope 5, and in turn to determine the location of the current targeted area 11 in the colon 7 which is within the field of view of the image capturing device 9 of the colonoscope 5.
  • the microprocessor 30 on determining the location of the current targeted area 11 in the colon 7, operates the flow controller 20 in response to the pressure read from the pressure sensor 24 to supply insufflating gas to the colon 7 at an appropriate rate in order to maintain the pressure in the colon 7 at the predefined pressure value appropriate to the location in the colon 7 within which the current targeted area 11 is located.
  • the colonoscope 5 As the colonoscope 5 is being withdrawn through the colon 7 and is being manoeuvred to sequentially scan the entire inner surface 14 of the colon wall 15, the captured images of the inner surfaces 14 of the colon wall 15 in the targeted areas 11 are sequentially displayed on the visual display screen 6 of the colonoscope 5, and the surgeon or clinician visually inspects targeted areas 11 sequentially displayed on the visual display screen 6 for the presence of a lesion.
  • the surgeon or clinician On detecting a lesion in or on a targeted area 11 , the surgeon or clinician operates the pedal operated switch 42 by depressing the foot pedal 43 to produce the lesion present signal indicative of detection of a lesion.
  • the microprocessor 30 in response to the lesion present signal operates the flow controller 20 to increase the supply of insufflating gas to the colon 7 to increase the pressure in the colon 7 from the current predefined pressure value to the elevated pressure by increasing the current predefined pressure value by the preset pressure increase amount, in this case by approximately 5mmHg, to in turn increase the working volume in the colon 7 to facilitate removal of the lesion.
  • the pressure in the colon 7 is maintained at the elevated pressure for so long as the lesion present signal remains active, in other words, for so long as the foot pedal 43 of the foot pedal operated switch 42 remains depressed by the surgeon or clinician to maintain the switch 42 in the closed circuit state.
  • the surgeon or clinician With the pressure in the colon 7 maintained at the elevated pressure, the surgeon or clinician as will be described in more detail below, removes the detected lesion.
  • the surgeon or clinician On completion of removal of the detected lesion, the surgeon or clinician removes his/her foot from the foot pedal 43, thereby operating the switch 42 into the open circuit state and deactivating the lesion present signal, and the microprocessor 30 operates the flow controller 20 to reduce the supply of insufflating gas to the colon 7 in order to reduce the pressure therein to the appropriate predefined pressure value corresponding to the location in the colon 7 within which the current targeted area 11 is located, and so operation of the apparatus 1 continues until the colonoscope 5 has been withdrawn through the entire length of the colon 7 from the cecum 39. In the absence of a lesion being detected in any of the targeted areas, the surgeon or clinician manoeuvres the colonoscope 5 to view the next adjacent targeted area 11.
  • the microprocessor 30 is also programmed to be responsive to a reduce pressure signal to operate the flow controller 20 to reduce the supply of insufflating gas to the colon 7 to reduce the colon pressure to a reduced pressure by reducing the current predefined pressure value or the current pressure at which the colon 7 is being insufflated by a preset pressure reduction amount.
  • the preset pressure reduction amount is also equal to approximately 5mmHg, although, the preset pressure reduction amount by which the colon pressure is reduced may lie in the range of 3mmHg to 8mmHg.
  • the reduce pressure signal is entered into the microprocessor 30 through the touchscreen interface 31.
  • the value of the preset pressure reduction amount may be prestored in the memory 37, or may be selectable, and if selectable the preset pressure reduction amount would be entered into the memory 37 through the touchscreen interface 31 when entering the value of the present pressure increase amount and/or the data relating to the subject into the memory 37 through the touchscreen interface 31.
  • the surgeon or clinician would require the colon pressure to be reduced by the preset pressure reduction amount in order to reduce tension in the colon wall which may be necessary on some occasions to enable grasping of a portion of the inner surface 14 of the colon wall 15 infected by a lesion, to enable removal of the lesion from the colon wall.
  • Figs. 5a to 5c the removal of one of the lesions 17, which in this case is a pre-cancerous polyp from the inner surface 14 of the colon wall 15 of one of the targeted areas 11 will now be described.
  • the colon 7 is maintained by the flow controller 20 at the elevated pressure or the reduced pressure, as the case may be.
  • a suitable snaring instrument in this case a snaring instrument 47 through the instrument channel 29 of the colonoscope 5 until a snare 48 extending from a distal end 49 of the snaring instrument 47 extends through the distal end 10 of the colonoscope 5 into the colon 7 adjacent the current targeted area 11.
  • the snare 48 of the snaring instrument 47 is then passed over the lesion 17, see Fig. 5a, and the snare 48 is withdrawn into the snaring instrument 47 through the distal end 49 thereof, see Fig. 5b, in order to sever the lesion 17 from the inner surface 14 of the colon wall 15 in the targeted area 11.
  • the foot pedal 43 of the foot pedal operated switch 42 is released, if it had been operated, to terminate the lesion present signal. If the reduce pressure signal had been entered through the touchscreen interface 31, a further signal would be entered through the touchscreen interface 31 to cancel the reduce pressure signal.
  • the microprocessor 30 is responsive to termination of the lesion present signal or to termination of the reduce pressure signal, as the case may be, to operate the flow controller 20 to reduce or increase, as the case may be, the supply of insufflating gas to the colon 7 in order to reduce or increase the pressure in the colon 7 to the predefined pressure value or the pressure value at which the colon 7 had been insufflated prior to activation of the lesion present signal or the reduce pressure signal.
  • any suitable appropriate instrument for removing any lesions such as adenomas or polyps may be used, and in some embodiments of the invention where suturing is required, a suitable suturing instrument will be urged through the instrument channel 29 of the colonoscope 5 after the snaring instrument 47 has been removed to complete any suturing which may be required at the site from which the lesion has been removed.
  • the microprocessor 30 may be programmed so that each alternate time the foot pedal operated switch 42 is operated, the microprocessor 30 would read the alternate lesion present signals as deactivation signals.
  • the microprocessor 30 would read the signal produced by the first operation of the foot pedal operated switch 42 as being a lesion present signal indicative of the detection of a lesion in the current targeted area requiring the pressure in the colon to be raised to the elevated pressure, and the signal produced by the second operation of the foot pedal operated switch 42 as being a signal indicative of the completion of the removal of a lesion, and thus indicating deactivation of the lesion present signal, and the microprocessor 30 would then operate the flow controller to reduce the colon pressure from the elevated pressure to the predefined pressure value at which the colon had been insufflated prior to the first operation of the foot pedal operated switch 42 to produce the second signal, or to the predefined pressure value corresponding to the location of the current targeted area 11. It is also envisaged that the microprocessor 30 may be programmed to interpret each alternate inputting of the reduce pressure signal through the touchscreen interface 31 as being indicative of termination of the reduce pressure signal, and to operate the flow controller 20 accordingly.
  • FIGs. 6 to 9 there is illustrated insufflating apparatus also according to the invention indicated generally by the reference numeral 50 for insufflating a vessel in the body of a human subject during a minimally invasive procedure for maintaining the topography of an inner surface of a wall of the vessel of a targeted area at a predefined degree of evenness, and also for detecting the presence of a lesion in or on the inner surface of the vessel in a targeted area thereof, for example, a pre-cancerous lesion, a pre-cancerous adenoma or a pre-cancerous polyp.
  • a lesion in or on the inner surface of the vessel in a targeted area thereof for example, a pre-cancerous lesion, a pre-cancerous adenoma or a pre-cancerous polyp.
  • the apparatus 50 comprises an insufflator 53 also according to the invention, a colonoscope 55 and an image recognition apparatus 56.
  • the apparatus 50 is adapted for use in a colon 57 of a subject 58, and the insufflator 53 is adapted for insufflating the colon 57 so that the topography 62 of an inner surface 64 of the colon wall 65 of a targeted area 61 adjacent a distal end 60 of the colonoscope 55, which is within the field of view of the colonoscope 55, is maintained at a predefined degree of evenness to enable detection of a lesion in or on the inner surface 64 of the colon wall 65 in the targeted area 61 , for example, a pre-cancerous lesion, a pre-cancerous adenoma and/or a pre-cancerous polyp, similar to the lesion 17 described with reference to the insufflating apparatus 1 of Figs. 1 to 5.
  • the insufflator 53 comprises a housing 72 within which a flow controller 74 is located for controlling the supply of insufflating gas to the colon 57.
  • the insufflator 53 is supplied with insufflating gas from an insufflating gas source 75 through a first inlet port 71 located in the housing 72.
  • the insufflating gas source 75 may be any suitable source, and in this embodiment of the invention comprises a source of pressurised carbon dioxide gas which is readily available in an operating theatre or an endoscopy suite of a hospital.
  • the insufflating gas from the insufflating gas source 75 is supplied to the flow controller 74 through the first inlet port 71.
  • the flow controller 74 is connected to the colonoscope 55 through a first outlet port 73 and a gas line 76 connected to the first outlet port 73 for delivering insufflating gas to the colon 57 through an insufflating gas channel 63 of the colonoscope 55.
  • a pressure sensor 80 located in the housing 72 is connected through a second outlet port 66 and a pressure monitoring line 81 to a suitable channel of the colonoscope 55 so that pressure in the colon 57 may be monitored by the pressure sensor 80 during insufflating of the colon 57.
  • the colon pressure may be monitored through, for example, and instrument channel 29 of the colonoscope 55, a vacuum channel, a channel purposed for suctioning or any other suitable channel.
  • the pressure sensor 80 produces a signal indicative of the colon pressure which is read by the microprocessor 77.
  • the microprocessor 77 is programmed to compare the colon pressure with a maximum pressure value stored in a memory 83 of the microprocessor 77, and if the colon pressure exceeds the maximum pressure value, the microprocessor 77 is programmed to output a pressure alert signal which is applied to a sounder 82 of the insufflator 53 to alert a surgeon or a clinician to the excessive pressure in the colon 57.
  • the maximum pressure value may be preset in a memory 83 of the microprocessor 77, or may be entered by the surgeon or clinician into the memory 83 through the touchscreen interface 79.
  • the image recognition apparatus 56 may be located in the housing 72 of the insufflator 53 or it may be provided separately from the insufflator 53. In this embodiment of the invention the image recognition apparatus 56 is provided separately from the insufflator 53.
  • the image recognition apparatus 56 comprises an image recognition means comprising an image recognition unit 84 located in a housing 78 of the image recognition apparatus 56.
  • the image recognition unit 84 reads signals from an image capturing device indicative of the inner surface 64 of the colon wall 65 of the targeted area 61 , which is within the field of view adjacent the distal end 60 of the colonoscope 55.
  • the value "1” in column two of the topography reference image look-up table 89 is indicative of the reference surface of the corresponding topography reference image 88 in column one of the topography reference image look-up table 89 being of topography of the predefined degree of evenness.
  • the topography of the reference surface of the predefined degree of evenness is representative of a substantially flat surface, of a degree of flatness sufficient to enable detection of a relatively small lesion in or on the inner surface 64 of the colon wall 65 of any of the targeted areas 61 when the degree of evenness thereof is of the predefined degree of evenness.
  • the colonoscope 55 is urged through the colon 57 to the cecum 96, and the microprocessor 77 operates the flow controller 74 to insufflate the colon 57 to a pressure of approximately 15mmHg.
  • the colonoscope 55 is then slowly withdrawn through the colon 57.
  • the surgeon or clinician manoeuvres the distal end 60 of the colonoscope 55 to scan the entire inner surface 64 of the colon wall 65 from one targeted area 61 to the next targeted area 61 within the field of view of the image capturing device 85 of the vision system of the colonoscope 55 from the cecum to the transition of the sigmoid colon 97 to the rectum 98.
  • the vision recognition unit 84 is adapted to operate in the first mode of operation. As the first one of the targeted areas 61 of the colon 57 is within the field of view of the image capturing device 85 of the colonoscope 55, the image recognition unit 84 commences to read the signal from the image capturing device 85 indicative of the captured image of the first and current targeted area 61 adjacent the cecum 96, and sequentially compares the current captured image with the topography reference images 88 and any corresponding additional topography reference images in column 1 of the topography reference image look-up table 89 until a match or a best match of the captured image with one of the topography reference images 88 or the additional topography reference images is determined.
  • the image recognition unit 84 On determining a match or a best match, the image recognition unit 84 produces the topography signal of value equal to the value in column two of the topography reference image look-up table 89 corresponding to the topography reference image 88 or the additional topography reference image with which the match or the best match is determined.
  • the microprocessor 77 On the current targeted area 61 being of the predefined degree of evenness, the microprocessor 77 outputs the lesion scan signal to the image recognition unit 84 to operate the image recognition unit 84 to operate in the second mode.
  • the image recognition unit 84 commences to compare the current captured image of the current targeted area 61 , which is now of the predefined degree of evenness, with the lesion reference images 90 and the additional lesion reference images, if any, of the lesions stored in column one of the lesion reference image look-up table 93. On completion of the comparison of the current captured image of the current targeted area 61 with the lesion reference images 90 and the additional lesion reference images, the image recognition unit 84 produces the lesion present signal of value zero in the absence of a lesion being detected.
  • the image recognition unit 84 produces the lesion present signal to be of the value in column two of the lesion reference image look-up table 93 corresponding to the value of the lesion reference image 90 in column one thereof, with which the captured image of the current targeted area 61 is a match or the best match thereof.
  • the microprocessor 77 produces the data signal which is applied to the touchscreen interface 79 indicating the absence of a lesion in the current targeted area, the microprocessor 77 outputs the signal to the image recognition unit 84 to return operation of the image recognition unit 84 to the first mode of operation. The surgeon or clinician then manoeuvres the colonoscope 55 to the next targeted area 61.
  • the microprocessor 77 outputs an alert signal to the sounder 82 to produce an audible alert signal alerting to the presence of a lesion in the targeted area 61, and a data signal is also applied by the microprocessor 77 to the touchscreen interface 79 to display a message thereon indicating the presence of a lesion in the current targeted area 61.
  • the microprocessor 77 also outputs a signal to the visual display screen 91 of the colonoscope 55 to highlight the image of the lesion and its location on the visual display screen 91 of the colonoscope 55 by encircling the image of the lesion on the visual display screen 91 with an image of a ring extending around the lesion.
  • the microprocessor 77 also in response to the lesion present signal being indicative of the presence of a lesion in the current targeted area 61 operates the flow controller 74 to increase the supply of insufflating gas to the colon 57 in order to raise the pressure in the colon by the preset pressure increase amount of 5mmHg above the current pressure to which the colon 57 is being insufflated, so that the colon is insufflated to the elevated pressure to increase the working volume within the colon 57.
  • the surgeon or clinician then severs the lesion from the targeted area 61.
  • the surgeon or clinician through the touchscreen interface 79 indicates completion of the severing of the lesion from the current targeted area 61, and the microprocessor 77 outputs the signal to the image recognition unit 84 to operate the image recognition unit 84 in the first mode, and operates the flow controller 74 to reduce the supply of insufflating gas to the colon 57 in order to return the colon pressure to the pressure at which the colon 57 had been insufflated up to the operation of the flow controller 74 by the microprocessor 77 in response to the lesion present signal from the image recognition unit 84.
  • the microprocessor 77 operates the flow controller 74 to increase the pressure in the colon 57 to the predefined pressure value to which the colon 57 had been insufflated prior to the inputting of the reduce pressure signal.
  • the surgeon or clinician then manoeuvres the colonoscope 55 to the next targeted area 61.
  • the image recognition unit 84 With the image recognition unit 84 again operating in the first mode, the image recognition unit 84 remains operating in the first mode until the inner surface 64 of the colon wall 65 of the now current targeted area 61 is of the predefined degree of evenness.
  • the microprocessor 77 outputs the lesion scan signal, and the image recognition unit 84 commences to operate in the second mode, and so operation of the insufflating apparatus 50 continues.
  • the microprocessor 77 during insufflating of the colon 57 reads the signal from the pressure sensor 80 and compares the read signal with the maximum pressure value stored in the memory 83. If at any time during the insufflating of the colon 57 the colon pressure exceeds the maximum pressure value, the microprocessor 77 outputs a pressure alert signal to the sounder 82 to warn the surgeon or clinician of the excessive pressure in the colon 57. It is envisaged that in some embodiments of the invention the microprocessor 77 may also be programmed to automatically operate the flow controller 74 to reduce the flow rate of insufflating gas to the colon in order to reduce the pressure therein to or below the maximum pressure value in the event of the colon pressure exceeding the maximum pressure value.
  • topography reference image look-up table 89 has been described as comprising only five topography reference images of degrees of evenness of values from “1” to “5”, it is envisaged that any number of topography reference images may be stored in the topography reference image look-up table of degrees of evenness greater than or less than 5 degrees of evenness.
  • topography reference image of the predefined degree of evenness has been described as being stored in the topography reference image look-up table 89 for comparison with each and every one of the targeted areas of the colon from the cecum 96 to the transitioning of the sigmoid colon 97 from the rectum 98, it is envisaged that a plurality of topography reference images of predefined degrees of evenness may be stored in the topography reference image look-up table 89 for the different parts of the colon.
  • the main difference between the insufflating apparatus 100 and the insufflating apparatus 1 lies in the generation of the location signal indicative of the location of the targeted area 11 in the colon 102 which is adjacent the distal end 107 of the colonoscope 105 and within the field of view of an image capturing device 115 located in the colonoscope 105 adjacent the distal end 107 thereof.
  • the location signal is produced by an image recognition apparatus 110 which is provided separate from the insufflator 104 and from the colonoscope 105.
  • the location reference images 113 are continuously updated by the application of one or more suitable artificial intelligence algorithm.
  • Each captured image which is a match or the best match with one of the location reference images 113 is passed through a learning module, and the captured image is then stored as an additional location reference image to the corresponding location reference image 113 in the location reference image look-up table as already described with reference to the updating of the reference images by the application of artificial intelligence to the topography and the lesion reference images of the topography and lesion reference image look-up tables of the insufflating apparatus 50 described with reference to Figs. 6 to 9.
  • the image recognition unit 112 may be adapted to also scan the captured image of each targeted area 11 for a lesion on the colon pressure being at the predefined pressure value corresponding to the current targeted area 11.
  • a lesion reference image look-up table similar to the lesion reference image look-up table of Fig. 8 of the insufflating apparatus 50 of Figs. 6 to 9 would be stored in the memory 114 of the image recognition apparatus 110.
  • the image recognition unit 112 would operate in a similar manner as the image recognition unit 84 of the insufflating apparatus 50 of Figs.
  • the location reference images are updated by artificial intelligence in a manner similar to that described for updating the reference images for the insufflating apparatus 50 described with reference to Figs. 6 to 9.
  • the captured image matching or being a best match of the relevant reference image is passed through a learning model 116 of the image recognition apparatus 110 and is then stored in the memory 114 as an additional location reference image, or as an additional lesion reference image, as the case may be, and as already described with reference to the insufflating apparatus 50 of Figs. 6 to 9.
  • FIG. 13 there is illustrated insufflating apparatus according to another embodiment of the invention indicated generally by the reference numeral 130 for insufflating a vessel, in this embodiment of the invention a colon of a subject during a minimally invasive procedure, which may be an investigative, surgical or other procedure.
  • the insufflating apparatus 130 will be described for insufflating a colon for the purpose of identifying and removing lesions therefrom.
  • the insufflating apparatus 130 comprises an insufflator 132 and a colonoscope 134.
  • the insufflator 132 is substantially similar to the insufflator 3 of the insufflating apparatus 1 described with reference to Figs.
  • the colonoscope 134 is substantially similar to the colonoscope 55 of the insufflating apparatus 50 described with reference to Figs. 6 to 9, and similar components are identified by the same reference numerals as those of the colonoscope 55 illustrated in Fig. 6.
  • the surgeon or clinician determines the location of the distal end 60 of the colonoscope 134 from the current captured image of the colon captured by the image capturing device 85 and displayed on the visual display screen 91 of the vision system of the colonoscope 134.
  • the surgeon or clinician inputs a signal indicative of the part of the colon within which the distal end 60 of the colonoscope 134 is located, and in turn within which the current targeted area 11 is located, as will be described below.
  • the insufflator 132 is provided with two foot pedal operated switches, namely, a first foot pedal operated switch 135 which is operated by a first foot pedal 136 and a second foot pedal operated switch 138 which is operated by a second foot pedal 139.
  • the first foot pedal operated switch 135 is provided to produce the location signal indicative of the location of the targeted area 11 in the colon 7 as will be described below.
  • the second foot pedal operated switch 138 is provided to produce the lesion present signal indicative of detection of a lesion 7 in the current targeted area 11 , in a similar manner as the foot pedal operated switch 42 of the insufflator 3 of the insufflating apparatus 1 of Figs. 1 to 5 produces the lesion present signal.
  • a pressure values look-up table similar to the pressure values look-up table 38 of Fig. 3 of the insufflating apparatus 1 is stored in the memory 37 of the microprocessor 30. Accordingly, use of the insufflating apparatus 130 in the insufflating of the colon 7 and the detection and removal of a lesion or lesions from the targeted areas is substantially similar to the operation of the insufflating apparatus 1 with the exception that the location signal is inputted to the microprocessor 30 through the first foot pedal operated switch 135.
  • the identity of the vessel, the sex, the age, the body mass index and the resting position of the subject during the procedure are entered into the microprocessor 30 through the touchscreen interface 31. If the preset pressure increase amount by which the current predefined pressure value is to be increased to the elevated pressure is selectable, it is also entered into the microprocessor 30 through the touchscreen interface 31. Thereafter, the surgeon commences to insert the colonoscope 134 anally into the colon 7. As the colonoscope 134 is being entered into the colon 7, the microprocessor 30 operates the flow controller to commence insufflating of the colon 7. The colonoscope 134 is then urged through the colon 7 to the cecum 39.
  • the surgeon or clinician operates the first foot pedal operated switch 135 by depressing the foot pedal 136 of the first foot pedal operated switch 135 to produce a first one of the location signals, which the microprocessor 30 is programmed to interpret as being indicative of the distal end of the colonoscope 134 being adjacent the cecum 39, and thus that the distal end 10 of the colonoscope 134 is located in the ascending colon 46.
  • the microprocessor 30 selects the appropriate predefined pressure value from column seven of the pressure values look-up table 38 corresponding to the pressure value for the targeted areas 11 being in the ascending colon 46.
  • the microprocessor 30 is programmed to maintain the pressure in the colon 7 at the appropriate predefined pressure value for the targeted areas 11 being in the ascending colon until the first foot pedal operated switch 135 is again operated by depressing the foot pedal 136 to produce a second one of the location signals when the distal end of the colonoscope 134 is located adjacent the transitioning of the ascending colon 46 to the transverse colon 40 as will be described below.
  • the surgeon or clinician manoeuvres the distal end 60 of the colonoscope 134 sequentially through targeted areas 11 of the inner surface 14 of the colon wall 15 so that the entire inner surface 14 of the colon wall 15 of the ascending colon 46 is fully scanned by the surgeon or clinician through the colonoscope 134.
  • the surgeon or clinician monitors the captured image of each targeted area 11 captured by the image capturing device 85 and displayed on the visual display screen 91 of the colonoscope 134 to detect a lesion in the displayed captured image of the targeted area 11 , and to ascertain the location of the distal end 60 of the colonoscope 134.
  • the surgeon or clinician On a lesion 17 being detected in any of the targeted areas 11 in the ascending colon 46, the surgeon or clinician operates the second foot pedal switch 138 by depressing the second foot pedal 139 to produce the lesion present signal indicative of the detection of a lesion in the current targeted area 11.
  • the surgeon or clinician then severs the polyp or other lesion as already described with reference to the insufflating apparatus 1.
  • the surgeon or clinician determines from the visual display screen 91 of the vision system of the colonoscope 134 that the distal end 60 of the colonoscope 134 is adjacent the transitioning of the ascending colon 46 to the transverse colon 40, the surgeon or clinician operates the first pedal switch 135 to produce a second one of the location signals.
  • the microprocessor 30 interprets the second one of the location signals as being indicative of the distal end 60 of the colonoscope 134 being adjacent the transitioning of the ascending colon 46 to the transverse colon 40, and in turn passing from the ascending colon 46 to the transverse colon 40.
  • the microprocessor 30 in response to the second one of the location signal obtains the predefined pressure value from the pressure values look-up table 38 in the memory 37 of the microprocessor 30 for the transverse colon 40, and operates the flow controller 20 to supply the insufflating gas to the colon 7 to insufflate the colon 7 to the predefined pressure value corresponding to the targeted areas 11 being in the transverse colon 40.
  • the microprocessor 30 continues to operate the flow controller 20 to maintain the pressure in the colon at the appropriate predefined pressure value for the targeted areas 11 being in the transverse colon 40, until the microprocessor 30 receives one of the lesion present signals from the second foot pedal switch 138 indicative of a lesion being detected, or a third one of the location signals from the first foot pedal switch 135 indicative of the distal end 60 of the colonoscope 134 being adjacent the transitioning of the transverse colon 40 to the descending colon 45 as will be described below. Operation of the insufflating apparatus 130 in the transverse colon 40 is similar to that described with reference to the ascending colon 46. The surgeon or clinician manoeuvres the distal end 10 of the colonoscope 134 through the transverse colon 40 and sequentially scans the targeted areas thereof in the transverse colon 40.
  • the surgeon or clinician determines from the visual display screen 91 of the vision system of the colonoscope 134 that the distal end 10 of the colonoscope 134 is adjacent the transitioning of the transverse colon 40 to the descending colon 45, the surgeon or clinician operates the first foot pedal operated switch 135 to produce the third one of the location signals.
  • the microprocessor 30 interprets the third one of the location signals as being indicative of the location of the distal end 60 of the colonoscope
  • the microprocessor 30 is responsive to the third one of the location signals to obtain the predefined pressure value for the descending colon 45 from the pressure values look-up table 38, and to operate the flow controller 20 to maintain the colon pressure at the appropriate predefined pressure value for the targeted areas 11 being in the descending colon until the microprocessor 30 receives a lesion present signal, or a fourth one of the signals indicative of the distal end 10 of the colonoscope 134 being adjacent the transitioning of the descending colon 45 to the sigmoid colon 41.
  • Operation of the insufflating apparatus 130 while the distal end 60 of the colonoscope 134 and in turn the targeted areas 11 are in the descending colon 45 is similar to the operation of the insufflating apparatus 130 while the distal end 10 of the colonoscope 134 is in the ascending colon 46 as described above.
  • the surgeon or clinician determines from the visual display screen 91 of the vision system of the colonoscope 134 that the distal end 60 of the colonoscope 134 is adjacent the transitioning of the descending colon 45 to the sigmoid colon 41, the surgeon or clinician operates the first foot pedal switch
  • the microprocessor 30 is responsive to the fourth one of the location signals to obtain the predefined pressure value for the sigmoid colon 41 from the pressure values look-up table 38, and to operate the flow controller 20 to maintain the pressure in the colon at the appropriate predefined pressure value for the targeted areas 11 being in the sigmoid colon 41, and so operation of the insufflating apparatus 130 continues as the distal end 60 of the colonoscope 134 is being manoeuvred through the sigmoid colon to sequentially scan the targeted areas 11 in the sigmoid colon as described with reference to the ascending colon 46.
  • the surgeon or clinician determines from the visual display screen 91 of the vision system of the colonoscope 134 that the distal end 60 of the colonoscope 134 has reached the transitioning of the sigmoid colon to the rectum, the surgeon or clinician operates the first foot pedal operated switch 135 to produce a fifth one of the location signals indicating to the microprocessor 30 that the procedure being carried out in the colon has been completed, and the microprocessor 30 operates the flow controller 20 to terminate insufflating of the colon, and the colonoscope 134 is withdrawn from the colon through the anus 35 of the subject, prior to insufflating of the colon being terminated.
  • the insufflating apparatus 130 and its use is similar to that of the insufflating apparatus 1.
  • the microprocessor 30 may be programmed to be responsive to the inputting of the first one to the fourth one of the location signals through the first foot pedal operated switch 135, to output respective corresponding signals to the visual display screen 91 of the vision system of the colonoscope 134, which would highlight the relevant part of the image of the colon, in which based on the first to the fourth ones of the location signal inputted through the first foot pedal operated switch 135 the colon is being insufflating to the predefined pressure value thereof based on the targeted areas being in that highlighted part of the colon.
  • FIG. 14 there is illustrated an insufflating apparatus according to a further embodiment of the invention indicated generally by the reference numeral 150.
  • the insufflating apparatus 150 is substantially similar to the insufflating apparatus 1 described with reference to Figs. 1 to 5, and similar components are identified by the same reference numerals.
  • the only difference between the insufflating apparatus 150 and the insufflating apparatus 1 is that the insufflator 3 of the insufflating apparatus 150 as well as being provided with the foot pedal operated switch 42, in this case a first foot pedal operated switch 42, is also provided with a second foot pedal operated switch 152, which is operated by a foot pedal 153.
  • the first foot pedal operated switch 42 is provided for inputting the lesion present signal as already described in the insufflating apparatus 1, and the microprocessor 30 is responsive to the lesion present signal for controlling the flow controller 20 to increase the supply of insufflating gas to the colon 7 for in turn increasing the colon pressure from the current predefined pressure value by the preset pressure increase amount to the elevated pressure.
  • the second foot pedal operated switch 152 is provided for inputting a reduce pressure signal to the microprocessor 30.
  • the microprocessor 30 is responsive to the reduce pressure signal for controlling the flow controller 20 to reduce the supply of insufflating gas to the colon for in turn reducing the pressure in the colon from the current pressure at which the colon is being insufflated by the preset pressure reduction amount to reduce the colon pressure to a reduced pressure.
  • the preset pressure increase amount and the preset pressure reduction amounts are of similar values, and each are approximately 5mmHg.
  • the surgeon or clinician may operate either the first or the second foot pedal operated switches 42 or 152, depending on whether the surgeon or clinician requires the colon pressure to be increased by the preset pressure increase amount or reduced by the preset pressure reduction amount.
  • the surgeon or clinician on detecting the presence of a lesion in the current targeted area, may initially operate the first foot pedal operated switch 42 to increase the colon pressure by the preset pressure increase amount in order to increase the working volume in the colon 7, and should the surgeon or clinician subsequently require the pressure in the colon 7 to be reduced, in order to reduce the tension in the colon wall to assist in grabbing the lesion, the surgeon or clinician may release the first foot pedal operated switch 42 to reduce the colon pressure to the predefined pressure value. Should a further reduction in the colon pressure below the predefined pressure value be required, the surgeon or clinician then operates the second foot pedal operated switch 152 in order to reduce the pressure in the colon 7 by the preset pressure reduction amount below the predefined pressure value.
  • the captured images of the targeted areas in the colon or other vessel in which the procedure is being carried out may be displayed on the visual display screen of the endoscope or colonoscope, and/or on a visual display screen of the insufflator.

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Abstract

L'invention concerne appareil d'insufflation (50) pour détecter une lésion dans le côlon d'un sujet humain ou animal, comprenant un insufflateur (53), un coloscope (55) et un appareil de reconnaissance d'image (56). Le coloscope (55) est introduit dans le côlon d'un sujet, et un dispositif de capture d'image (85) du coloscope (55) capture une image d'une zone ciblée du côlon qui est appliquée à l'appareil de reconnaissance d'image (56). L'appareil de reconnaissance d'image (56) compare l'image capturée à une pluralité d'images de référence de topographies de différents degrés d'uniformité jusqu'à un degré prédéfini d'uniformité approprié pour permettre la détection d'une lésion. Un microprocesseur (77) de l'insufflateur (53) lit un signal de topographie provenant de l'appareil de reconnaissance d'image (56) indiquant le degré d'uniformité de la zone ciblée du côlon et actionne un régulateur de débit pour accroître le débit de gaz d'insufflation vers le côlon jusqu'à ce que la zone ciblée atteigne le degré d'uniformité prédéfini, auquel stade l'appareil de reconnaissance d'image (56) compare l'image capturée à des images de référence de lésion pour détecter une lésion dans la zone ciblée si celle-ci est présente.
PCT/IE2025/000001 2024-01-09 2025-01-09 Insufflateur, appareil d'insufflation et procédé d'insufflation dans un vaisseau du corps d'un sujet humain ou animal Pending WO2025150034A2 (fr)

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Publication number Priority date Publication date Assignee Title
US20060129087A1 (en) * 2004-03-31 2006-06-15 Takefumi Uesugi Method and apparatus for supplying predetermined gas into body cavities of a patient
WO2007033379A2 (fr) * 2005-09-14 2007-03-22 Neoguide Systems, Inc. Procédés et appareil pour effectuer des procédures transluminales et autres
KR101326417B1 (ko) * 2006-01-13 2013-11-11 올림푸스 메디칼 시스템즈 가부시키가이샤 내시경용 오버튜브
US10736500B2 (en) * 2014-04-28 2020-08-11 Universidad Del A Sabana System and method for measuring sensory response of tissue
EP3215205B1 (fr) * 2014-11-05 2019-10-09 Palliare Limited Appareil pour commander le gonflement d'une cavité corporelle au cours d'une procédure chirurgicale ou d'un examen et système de gonflement de cette cavité
WO2017201494A1 (fr) * 2016-05-19 2017-11-23 Avantis Medical Systems, Inc. Procédés de détection de polypes
US11511034B2 (en) * 2017-03-19 2022-11-29 Motus Gi Medical Technologies Ltd. Colon evacuation without collapse
WO2023126999A1 (fr) * 2021-12-27 2023-07-06 日本電気株式会社 Dispositif de traitement d'image, procédé de traitement d'image et support de stockage
WO2023175596A2 (fr) * 2022-03-16 2023-09-21 Palliare Limited Insufflateur et endoscope, système d'insufflation et procédé d'exécution d'une procédure comprenant un insufflateur et un endoscope

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